The present invention relates to medical devices, particularly to an introducer element to assist in the placement of a medical device into a body, and more particularly to an introducer element to assist in the placement of a sensor into brain tissue.
Most medical patients require monitoring of one or more of their medical functions during hospitalization and/or during home-treatment. Chief among the concerns regarding the monitoring process is that the measurements obtained from monitoring instrumentation are as accurate as possible. In order to provide accurate measurements, however, the monitoring instrumentation must be placed at an exact location within the body, and the monitoring instrumentation must not migrate from this exact position during the monitoring process. Other concerns related to the monitoring process are that the monitoring instrumentation can be easily inserted and positioned without the need for numerous devices that could complicate the procedure, that the monitoring instrumentation is easily removable once in place, and that the entire monitoring process reduces trauma to the tissue of the patient as much as possible.
The above concerns are especially relevant with regard to a sensor that is inserted into brain tissue in order to measure characteristics of the brain, such as O2, CO2, pH and temperature. These sensors tend to be flexible yet fragile, and thus have proven to be difficult to initially place within brain tissue without support and to assuredly secure at a desired depth within brain tissue.
Therefore, a need exists for a device and technique that provides safe, simple and effective introduction, securing, and sealing of a medical instrument into a body. In particular, a need exists for a device and technique that provides safe, simple and effective introduction and securing of a flexible sensor into brain tissue for monitoring purposes.
The present invention provides an introducer element. Although the invention is primarily shown and described as being used to effectuate the placement of a sensor into brain tissue, it is understood that the invention has other applications as well, such as to effectuate the placement of a medical device into other areas of the body.
The introducer element includes a body that has a longitudinal axis and that is divided into first, second, third and fourth housing areas. The third housing area is connected to the first, second and fourth housing areas and is disposed between the first and fourth housing areas as well as the second and fourth housing areas.
The first housing area includes at least a first lumen, and the second housing area includes at least a second lumen. A quantity of peel-away tubing is disposed within the second lumen, wherein at least a portion of the peel-away tubing is also located outside of the second lumen, and wherein the tubing has a slit defined therein.
The first and second lumen are separate from each other in the first and second housing areas of the introducer element body but are merged to form a combined lumen within either the third or fourth housing area.
The introducer element also includes a guide/splitting tube, which is generally disposed within the first lumen, and which passes through the slit defined within the quantity of peel-away tubing. The guide/splitting tube provides a path between the first lumen and the combined lumen. The combined lumen is also defined so as to be substantially internally lined by the quantity of peel away tubing.
In an exemplary embodiment of the present invention, the first and fourth housing areas of the body are substantially coaxial with the longitudinal axis of the body, while the second housing area is offset from the longitudinal axis of the body.
The introducer element may be used in conjunction with other equipment to insert a medical instrument, such as a sensor, into an area of the body, such as brain tissue.